Therapy Detail
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| Therapy Name | Sotorasib |
| Synonyms | |
| Therapy Description |
Sotorasib (AMG 510) is small molecule inhibitor that selectively targets KRAS G12C, which may result in inhibition of tumor growth (J Clin Oncol 37, 2019 (suppl; abstr 3003)). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Sotorasib | Lumakras | AMG 510|AMG510|AMG-510 | KRAS G12C inhibitor 25 | Lumakras (sotorasib) is small molecule inhibitor that selectively targets KRAS G12C and inhibits downstream signaling, which may lead to growth inhibition of tumors harboring KRAS G12C (PMID: 31666701). Lumakras (sotorasib) is FDA approved for use in patients with locally advanced or metastatic non-small cell lung cancer harboring KRAS G12C who have received one or more prior therapy (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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- Use quotes to match a longer phrase which contains spaces "mtor c1483f"
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04667234 | Expanded access | Sotorasib | Expanded Access of AMG 510 (pINN Sotorasib) | Available | USA | 5 |
| NCT04185883 | Phase I | Sotorasib | AMG 510 (pINN) Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) | Recruiting | USA | ESP | DEU | CAN | BEL | AUT | 3 |
| NCT05398094 | Phase II | Sotorasib | Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy (MERIT-lung) | Recruiting | ESP | 0 |
| NCT03600883 | Phase Ib/II | Sotorasib + unspecified PD-1 antibody Sotorasib + unspecified PD-L1 antibody Sotorasib | A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of AMG 510 in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreak 100) | Recruiting | USA | FRA | ESP | DEU | CAN | BEL | AUT | 9 |
| NCT04303780 | Phase III | Sotorasib Docetaxel | Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 16 |
| NCT04933695 | Phase II | Sotorasib | A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment (CodeBreaK201) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | BEL | 4 |
| NCT04625647 | Phase II | Sotorasib | Testing the Use of Targeted Treatment (AMG 510) for KRAS G12C Mutated Advanced Non-squamous Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial) | Recruiting | USA | 1 |
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